Adding New Drugs for HIV Infected Patients Failing Current Therapy

• Status: Completed
• Trial end date: 2004-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Even though powerful anti-HIV drug combinations have been successful in patients with little or no prior anti-HIV therapy, studies have shown that these treatments are less effective in patients who have been treated with nucleoside analogues. This study will test the safety and effectiveness of adding one or two new drugs to a personalized anti-HIV regimen for patients whose previous HIV treatments have failed.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Enfuvirtide

Criteria

Note: Enrollment into this study was permanently closed on 02/09/04.

Inclusion Criteria:

• HIV infected

• Taken at least two combination anti-HIV treatments containing three or more drugs. In total, the treatments must have lasted at least 24 months and must have included at least two nucleoside reverse transcriptase inhibitors (NRTIs), two protease inhibitors (PIs), and one nonnucleoside reverse transcriptase inhibitor (NNRTI).

• Failed two previous combination treatments of three or more drugs

• Viral load of more than 5000 copies/ml on stable (at least 8 weeks) antiretroviral regimen, within 60 days prior to study entry

• Willing to stay on the current failing anti-HIV treatment until starting study treatment; may have to remain on failing regimen for an additional 60 days after study screening

• Willing to use acceptable methods of contraception

• Access to optimized background (OB) regimen drugs

• Ability to bring OB regimen drugs to screening visit

Exclusion Criteria:

• Prior use of DAPD or ENF

• Drug or alcohol use which, in the opinion of the investigator, would interfere with the study

• History of any illness that, in the opinion of the investigator, would interfere with study participation

• Single kidney or history of two or more episodes of kidney stones

• Pregnant or breastfeeding

• Experimental anti-HIV drug use or use of any agent that acts on the immune system within 60 days prior to entry

• Active immunization within 21 days prior to study entry

• Acute therapy for a serious infection or illness

• Active AIDS-defining opportunistic infection requiring acute treatment

• Unexplained fever within 7 days prior to study entry

• Cancer that requires chemotherapy

• Prior HIV vaccination, except for subunit vaccines that contained only gp120

• Certain mutations in HIV-1 reverse transcriptase

• Measurable loss of vision due to lens opacity

• Posterior subcapsular cataract

• Cortical cataract of Grade C3 or higher on the Lens Opacities Classification System III (LOCS III) scale

• Nuclear opalescence Grade NO3 (LOCS III) or higher

• Best corrected vision worse than 20/200

• Diabetes mellitus. Gestational diabetes is not excluded.